68Ga-FAP-RGD PET/CT : Dosimetry and Preliminary Clinical Translational Studies

Phase 1

Recruiting

• Conditions: Tumor
• Interventions: Drug: 68Ga-FAP-RGD

• Registration Number: NCT05515783
• Lead Sponsor: First Affiliated Hospital of Fujian Medical University

Brief Summary

As an new dual targeting PET radiotracer, 68Ga-FAP-RGD is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-FAP-RGD in patients with various types of cancer and compared them with the results of 68Ga-FAPI-02 or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 68Ga-FAP-RGD.

Detailed Description

Fibroblast activation protein (FAP) is highly expressed in the stroma of a variety of human cancers and is therefore considered promising for guiding targeted therapy. The recent development of quinoline-based PET tracers that act as FAP inhibitors (FAPIs) demonstrated promising results preclinically and already in a few clinical cases. Integrin αvβ3 is restrictedly expressed on angiogenic blood vessels and tumour cells. It plays a key role in angiogenesis for tumour growth and metastasis. RGD peptide can specifically recognise the integrin αvβ3, which serves as targeted molecular for anti-angiogenesis strategies. 68Ga-FAP-RGD is a novel dual targeting tracers. The present study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of 68Ga-FAP-RGD, and performed a head-to-head comparison with 68Ga-FAPI-02 or 18F-FDG PET/CT scans in patients with various cancers.

Study Timeline

• Study Start: 2022-05-01
• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-08-23
• Study First Posted: 2022-08-25
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-16
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Various solid tumors with available histopathological findings
• Signed informed consent

Exclusion Criteria

• pregnant or lactational women
• who suffered from severe hepatic and renal insufficiency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part I: safety, tolerability, biodistribution and dosimetry	68Ga-FAP-RGD	PET imaging will begin at 30s (30s/bed), 15min (1min/bed), 30min (2 min/bed), 60min (2 min/bed) and 120min (2 min/bed) after injection
Part II: diagnostic efficacy	68Ga-FAP-RGD	Participants with various types of cancer will have PET imaging 50-100 minutes after injection of 68Ga-FAP-RGD and another agent (68Ga-FAPI-02 or 18F-FDG).

Primary Outcome Measures

Name	Time	Method
Human dosimetry	From right after tracer injection to 2-hours post-injection	radiation dose to individual organs and the equivalent dose for the whole body of each subject and as a mean over all subjects (Part I). Dosimetry will be calculated using the Hybrid-Dosimetry software.
Standard uptake value (SUV)	Up to 2 weeks	Determination of SUV for detected lesions and discernible organs of 68Ga-FAP-RGD and 68Ga-FAPI-02 or 18F-FDG
the accuracy of 68Ga-FAP-RGD PET/CT	Up to 2 weeks	compared with pathology or composite imaging, the accuracy of 68Ga-FAP-RGD PET/CT was evaluated.
Human biodistribution	From right after tracer injection to 2-hours post-injection	reported as relative uptake values per organ at 30s, 15min, 30min, 60min and 120 min per individual subject and as a mean over all subjects (Part I)
Lesion numbers	Up to 2 weeks	Determination of lesion numbers of 68Ga-FAP-RGD and 68Ga-FAPI-02 or 18F-FDG
the sensitivity of 68Ga-FAP-RGD PET/CT	Up to 2 weeks	compared with pathology or composite imaging, the sensitivity of 68Ga-FAP-RGD PET/CT was evaluated.
the specificity of 68Ga-FAP-RGD PET/CT	Up to 2 weeks	compared with pathology or composite imaging, the specificity of 68Ga-FAP-RGD PET/CT was evaluated.

Secondary Outcome Measures

Name	Time	Method
Count of participants with treatment emergent adverse events	Up to 3 days	The frequency and severity of treatment emergent adverse events following 68Ga-FAP-RGD injection will be descriptively reported as classified and graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

Trial Locations

Locations (1)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China